Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr

ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of South Florida

About this trial

The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

6-12 yrs

Verbal IQ > 70 (to ensure verbal skills are sufficient to participate in treatment)

participation of child's parent or legal guardian living in the same home

child diagnosed with insomnia, 5) willing to accept random assignment.

Disqualifiers

child unable to provide informed consent or child unable to provide assent

child unwilling to accept random assignment

child participation in another randomized research project

child unable to complete forms or implement treatment procedures due to cognitive impairment

Trial design

Design model

Crossover

Treatments tested in this trial

  • CBT-I

    Behavioral

    Cognitive behavioral therapy for insomnia

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CBT-IExperimental treatment 1 intervention
Group B: Waitlist ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Electronic Sleep Diaries - Child

Primary: child sleep onset latency (lights-out until sleep onset) and total sleep time. All other sleep diary variables are secondary (e.g., sleep efficiency (total sleep time/time in bed x 100%). Child (with caregiver assistance) and caregiver complete electronic diaries each morning (\~5 mins) during each 1-week assessment and throughout treatment.

Time frame
baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
2

Actigraphy - Child

Primary variables: child sleep onset latency and total sleep time. All other actigraphy variables are secondary. Children wear actigraphs (Fitbit Inspire 3, Google), watch-like device, that monitors light and gross motor activity. Data analyzed using 30s epochs. Validated algorithm estimates SOL, TST, WASO, sleep efficiency and other variables provided by diaries. A combination of diary and actigraphy data estimates bed/waketime variability. Children wear devices 24/7 during each 1-week assessment.

Time frame
baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
3

Session Completion

Percentage of treatment sessions completed

Time frame
within 1 week post-treatment
4

Treatment Adherence

Percentage of instructions followed as indicated on treatment adherence logs

Time frame
within 1 week post-treatment

Secondary outcomes

1

Child Sleep Habits Questionnaire-Abbreviated

The Child Sleep Habits Questionnaire - Abbreviated consists of 22 questions regarding child sleep behaviors on a 1 point scale (0 = never, 7 = always). Higher scores indicating issues with sleep habits.

Time frame
baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
2

Pediatric Symptom Checklist-17

The Pediatric Symptom Checklist-17 is a 17-item questionnaire that measures attention, internalizing, and externalizing problems on a 0-2 scale. Scores range from 0-34 with higher score indicates a greater level of psychosocial impairment.

Time frame
baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
3

Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2)

The Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2) is an 86-item caregiver-report measure of day-to-day executive functioning and impairment. T-scores ranging from 30-90 with higher scores indicating greater executive functioning difficulties

Time frame
baseline, within 1 week post treatment, 1 month follow up, 3 month follow up
4

Pediatric Daytime Sleepiness Scale

The Pediatric Daytime Sleepiness Scale is an 8-item questionnaire that measures daytime sleepiness and school-related outcomes on a 5-point scale. Scores range from 0-32 with higher scores indicating greater daytime sleepiness.

Time frame
baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Other outcomes

1

Pubertal Development Scale (PDS)

Self-report questionnaire used to assess pubertal status

Time frame
baseline, within 1 week post treatment, 1 month follow up, 3 month follow up

Sponsors and contacts

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